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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00077194 |
RATIONALE: Drugs used in chemotherapy, such as FR901228, work in different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: This phase II trial is studying how well FR901228 works in treating patients with relapsed or refractory non-Hodgkin's lymphoma.
Condition | Intervention | Phase |
---|---|---|
Lymphoma |
Drug: romidepsin |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study Of Depsipeptide, A Histone Deacetylase Inhibitor, In Relapsed Or Refractory Mantle Cell Or Diffuse Large Cell Non-Hodgkin's Lymphoma |
Study Start Date: | January 2004 |
OBJECTIVES:
OUTLINE: This is a multicenter study.
Patients receive FR901228 (depsipeptide) IV over 4 hours on days 1, 8, and 15. Treatment repeats every 28 days for at least 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months until 5 years from study registration.
PROJECTED ACCRUAL: A total of 16-35 patients will be accrued for this study within 8-24 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed aggressive B-cell non-Hodgkin's lymphoma of 1 of the following cellular types:
Relapsed or refractory disease
Measurable disease
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Pulmonary
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, District of Columbia | |
Howard University Cancer Center at Howard University Hospital | |
Washington, District of Columbia, United States, 20060 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201-1379 | |
United States, Wisconsin | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792-5256 |
Study Chair: | Nancy L. Bartlett, MD | Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis |
Study ID Numbers: | CDR0000349660, MAYO-MC0287, NCI-5961 |
Study First Received: | February 10, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00077194 |
Health Authority: | United States: Federal Government |
recurrent adult diffuse large cell lymphoma recurrent mantle cell lymphoma recurrent adult Burkitt lymphoma |
Lymphoma, Large B-Cell, Diffuse Immunoproliferative Disorders Lymphoma, Mantle-Cell Lymphoma, small cleaved-cell, diffuse Romidepsin Mantle cell lymphoma Recurrence |
Lymphoma, large-cell Lymphatic Diseases Burkitt's lymphoma Burkitt Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |
Neoplasms Neoplasms by Histologic Type Immune System Diseases Antineoplastic Agents |
Therapeutic Uses Antibiotics, Antineoplastic Pharmacologic Actions |